MAUDE Adverse Event Report: CORINDUS, INC. CORPATH GRX SYSTEM

Model Number	303
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A corindus service engineer inspected the touchscreen and determined that it contained particles from an ammonium salt based cleaning solution.The corpath grx operator's manual states that "isopropyl alcohol (ipa) based disinfectants, germicides such as spor-klenz, or 10% to 20% bleach solutions" are recommended for cleaning.The use of an alternate cleaning solution may have led to the failure of the robotic drive touchscreen.The service engineer replaced the touchscreen and system is now functioning as intended.
Event or Problem Description
The robotic drive touchscreen became unresponsive when the technician selected "load/exchange device" to remove the guidewire.The system was rebooted but the "continue case" button could not be selected due to the unresponsive touchscreen.The emergency release button on the cassette had to be pressed to disassemble the cassette and remove the interventional devices from the patient.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• MDR Report Key: 7713953
• Report Number: 3007822508-2018-00005
• Device Sequence Number: 903776
• Product Code: DXX
• UDI-Device Identifier: 00816280023031
• UDI-Public: (01)00816280023031(11)170301
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 303
• Device Catalogue Number: 303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1